DystoniaNCT07323602
Predicting DBS Outcomes in Dystonia Using Wearable Gait Sensors
An observational study of Dystonia, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to investigate whether preoperative gait characteristics, measured by wearable sensors, can predict the clinical outcomes of Deep Brain Stimulation (DBS) in patients with dystonia. Participants scheduled for DBS surgery will undergo gait analysis using wearable sensors before the procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dystonia
- What is being tested?
- Wearable Gait Sensor Analysis
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients clinically diagnosed with isolated dystonia who are candidates for Deep Brain Stimulation (DBS) surgery at Ruijin Hospital. These participants have motor symptoms that are refractory to optimal medical therapy and are scheduled for elective surgical intervention.
Who may be able to join
- Clinically diagnosed with primary or isolated dystonia.
- Scheduled to undergo bilateral Deep Brain Stimulation (DBS) surgery.
- Able to walk independently or with assistance (sufficient to perform gait analysis).
- Willing to participate and sign informed consent.
Who cannot join
- History of other neurological disorders affecting gait (e.g., stroke, severe neuropathy).
- Significant orthopedic issues preventing gait assessment.
- Cognitive impairment preventing cooperation with study procedures.
- Previous functional neurosurgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Li, +0086-021-64370045, ldy11483@rjh.com.cn
About this study
Official title: Prediction of Deep Brain Stimulation (DBS) Efficacy in Patients With Dystonia Based on Preoperative Wearable Gait Analysis: A Prospective Observational Study
This study aims to investigate whether preoperative gait characteristics, measured by wearable sensors, can predict the clinical outcomes of Deep Brain Stimulation (DBS) in patients with dystonia. Participants scheduled for DBS surgery will undergo gait analysis using wearable sensors before the procedure. Clinical assessments, including the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the SF-36 Health Survey, will be conducted preoperatively and postoperatively to evaluate surgical efficacy and quality of life. The study seeks to identify gait biomarkers that correlate with optimal DBS response.
Read the detailed description
This study aims to investigate whether preoperative gait characteristics, measured by wearable sensors, can predict the clinical outcomes of Deep Brain Stimulation (DBS) in patients with dystonia. Participants scheduled for DBS surgery will undergo gait analysis using wearable sensors before the procedure. Clinical assessments, including the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the SF-36 Health Survey, will be conducted preoperatively and postoperatively to evaluate surgical efficacy and quality of life. The study seeks to identify gait biomarkers that correlate with optimal DBS response.
- Conditions
- Dystonia
- Being tested
- Wearable Gait Sensor Analysis
- Keywords
- dystonia, deep brain stimulation, wearable Gait Analysis
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Gait Sensor AnalysisDevice
Patients will wear inertial measurement units (IMUs) on [specify body parts, e.g., lower back, ankles] to record gait data during standardized walking tasks before surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Baseline Gait Features and BFMDRS Improvement
Measured: Through study completion, up to 6 months
Secondary outcomes (3)
Change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) Score
Measured: Baseline (pre-operative) and 6 months post-operative
Change in SF-36 Quality of Life Score
Measured: Baseline (pre-operative) and 6 months post-operative
Gait Characteristics (Spatio-temporal parameters)
Measured: Baseline (pre-operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Aug 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Sceneray Medical Co. , Ltd, Beijing Pins Medical Co., Ltd, Medtronic
- Responsible party
- Principal investigator, LI DIANYOU, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323602
- Sponsor's protocol ID
- DYSGAITpredictDBS
- Status last verified
- Nov 2025
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Deep Brain Stimulation (DBS) Efficacy in Patients With Dystonia Based on Preoperative Wearable Gait Analysis: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07323602
- Acronym / sponsor ID
- DYSGAITpredictDBS
- Conditions
- Dystonia
- Keywords
- dystonia, deep brain stimulation, wearable Gait Analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Suzhou Sceneray Medical Co. , Ltd, Beijing Pins Medical Co., Ltd, Medtronic
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether preoperative gait characteristics, measured by wearable sensors, can predict the clinical outcomes of Deep Brain Stimulation (DBS) in patients with dystonia. Participants scheduled for DBS surgery will undergo gait analysis using wearable sensors before the procedure. Clinical assessments, including the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the SF-36 Health Survey, will be conducted preoperatively and postoperatively to evaluate surgical efficacy and quality of life. The study seeks to identify gait biomarkers that correlate with optimal DBS response.
Detailed description
This study aims to investigate whether preoperative gait characteristics, measured by wearable sensors, can predict the clinical outcomes of Deep Brain Stimulation (DBS) in patients with dystonia. Participants scheduled for DBS surgery will undergo gait analysis using wearable sensors before the procedure. Clinical assessments, including the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the SF-36 Health Survey, will be conducted preoperatively and postoperatively to evaluate surgical efficacy and quality of life. The study seeks to identify gait biomarkers that correlate with optimal DBS response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients clinically diagnosed with isolated dystonia who are candidates for Deep Brain Stimulation (DBS) surgery at Ruijin Hospital. These participants have motor symptoms that are refractory to optimal medical therapy and are scheduled for elective surgical intervention.
Key inclusion criteria (4 listed)
- Clinically diagnosed with primary or isolated dystonia.
- Scheduled to undergo bilateral Deep Brain Stimulation (DBS) surgery.
- Able to walk independently or with assistance (sufficient to perform gait analysis).
- Willing to participate and sign informed consent.
Key exclusion criteria (4 listed)
- History of other neurological disorders affecting gait (e.g., stroke, severe neuropathy).
- Significant orthopedic issues preventing gait assessment.
- Cognitive impairment preventing cooperation with study procedures.
- Previous functional neurosurgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Gait Sensor AnalysisPatients will wear inertial measurement units (IMUs) on [specify body parts, e.g., lower back, ankles] to record gait data during standardized walking tasks before surgery. | Device | – |
Primary outcome
Correlation between Baseline Gait Features and BFMDRS Improvement
Time frame: Through study completion, up to 6 months
3 secondary outcomes
Change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) Score
Time frame: Baseline (pre-operative) and 6 months post-operative
Change in SF-36 Quality of Life Score
Time frame: Baseline (pre-operative) and 6 months post-operative
Gait Characteristics (Spatio-temporal parameters)
Time frame: Baseline (pre-operative)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dystonia, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li (+0086-021-64370045, ldy11483@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Baseline Gait Features and BFMDRS Improvement (time frame: Through study completion, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.